Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03969290
Recruitment Status : Completed
First Posted : May 31, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

Condition or disease Intervention/treatment Phase
Refractive Errors Device: Verofilcon A contact lenses Device: Etafilcon A contact lenses Not Applicable

Detailed Description:
The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Contralateral
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Performance of Two Daily Disposable Contact Lenses - Study 1
Actual Study Start Date : June 5, 2019
Actual Primary Completion Date : August 5, 2019
Actual Study Completion Date : August 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence 1
Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.
Device: Verofilcon A contact lenses
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Other Name: Precision1™

Device: Etafilcon A contact lenses
Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Other Name: Acuvue® Moist

Active Comparator: Sequence 2
Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.
Device: Verofilcon A contact lenses
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Other Name: Precision1™

Device: Etafilcon A contact lenses
Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Other Name: Acuvue® Moist




Primary Outcome Measures :
  1. End of day (EOD) visual acuity at distance [ Time Frame: Day 1, after 8 hours of wear ]
    Visual acuity (VA) will be measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to understand and sign an approved Informed Consent form
  • Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day
  • Best corrected VA of logMAR 0.10 or better in each eye
  • Willing to discontinue artificial tears and rewetting drops during the study
  • Able to wear contact lenses within the protocol-specified sphere power range
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator
  • History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
  • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment
  • Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses
  • Other protocol-specified exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969290


Locations
Layout table for location information
Germany
Alcon Investigative Site
Jena, Germany, 07745
Sponsors and Collaborators
Alcon Research
Investigators
Layout table for investigator information
Study Director: Alcon Research Alcon Research

Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03969290     History of Changes
Other Study ID Numbers: CLE383-P001
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alcon Research:
Contact lens
Vision correction
Visual acuity
Daily disposable contact lens
Additional relevant MeSH terms:
Layout table for MeSH terms
Refractive Errors
Eye Diseases